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Surgical Stress Measured by Microdialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01495143
First received: December 29, 2009
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study is to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD).


Condition Intervention
Trauma
 Procedure: Posterolateral lumbar fusion surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Microdialysis of Paraspinal Muscle in Healthy Volunteers and Patients Underwent Posterior Lumbar Fusion Surgery

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • The glycerol concentration [ Time Frame: Two hours ] [ Designated as safety issue: No ]
    To study whether the glucerol concentration can be used to evaluate surgery related paraspinal muscle damage


Enrollment: 16
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy group
Eight healthy volunteers (five males and three females) with a body mass index of 23.8 and without chronic metabolic disease or low back pain. They are all non-smokers and non-medicated.
 Procedure: Posterolateral lumbar fusion surgery
Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.
Other Name: Lumbar diseases
Experimental: Surgery group

Two MD catheters is placed in the paraspinal muscle at the level of midpoint of incision bilaterally.

A reference catheter is placed in the deltoid muscle.

 Procedure: Posterolateral lumbar fusion surgery
Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.
Other Name: Lumbar diseases

Detailed Description:

Posterior approach is a common and important surgical procedure for various lumbar diseases. Owing to the anatomy, the damage of paraspinal muscle is inevitable during conventional posterior lumbar fusion surgery. Degeneration and malfunction of the paraspinal muscle might associate with pain and inferior postoperative clinical outcome.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • patients who undergo conventional instrumented posterolateral lumbar fusion.

Exclusion criteria:

  • previous fusion
  • chronic metabolic disease
  • tumor or metastasis
  • postoperative surgical complications and complications during surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495143

Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Principal Investigator: Gang Ren, MD, PhD Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01495143     History of Changes
Other Study ID Numbers: ON-07-012-RAS
Study First Received: December 29, 2009
Last Updated: May 1, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Glucose
Lactate pyruvate ratio
Glycerol
Paraspinal muscle
Microdialysis

ClinicalTrials.gov processed this record on June 17, 2013